The AIDS epidemic is traced back to the June 5, 1981 volume of Mortality and Morbidity Weekly Report which contains a description by Michael Gottlieb of five cases of Pneumocystis carinii pneumonia in homosexual men. (CDC., MMWR 30:250 (1981)) After the information of additional cases of severe immunosuppression in young men accumulated, the disease became known as "Acquired Immune Deficiency Syndrome." Since the discovery of this syndrome, over 130,000 Americans have been diagnosed with AIDS and over 80,000 died.
One of the most interesting features of dysfunction of the immune system in individuals suffering from AIDS is decreased T4 lymphocyte count and increased T8 lymphocyte count resulting in reverse ratio of T4 and T8 cells (helper/suppressor ratio). The main efforts in the initial study of the disease concentrated on the isolation of the causative agent. The discovery of such agent called "HTLV-III" was initially announced by Robert Gallo of the National Cancer Institute (Gallo et al., Science, 220:865 (1983)). Approximately at the same time, a group of French researchers, headed by Luc Montagnier, reported isolation of Lymphadenopathy Associated Virus (LAV). These two newly discovered viruses were found to be identical and since 1986 have been officially called Human Immunodeficiency Virus (HIV). In spite of the fact that a majority of scientists believe that AIDS is caused by HIV, some researchers have produced evidence that HIV is not a causative agent (Duesberg Proc. Natl. Acad. Sci. U.S.A., 86:755 (1989)). The researcher credited with discovery of HIV now believes that mycoplasma helps the virus to produce the disease (Montagnier, Res. Virol., 141:5 (1990)).
Regardless what the causative agent is, a common consent among the researchers is that AIDS is a disease characterized by progressive dysfunction of the immune system. T4 and T8 lymphocytes, which are the affected cells of the immune system, develop according to the program encoded in the DNA of the cell. In an HIV infected cell, the program in DNA also contains the fragment corresponding to viral RNA, which was transcribed through reverse transcriptase. The presence of such a program causes the T4 cell to malfunction and live a much shorter life and T8 cells to multiply more rapidly. The decrease of T4 lymphocyte count and increase of T8 lymphocyte count will cause progressive failure of the immune system manifested by opportunistic infections and neoplastic diseases associated with AIDS, ultimately leading to the patient's death.
So far, no cure for AIDS has been found. Most of the therapeutic approaches are employing antiviral therapy, such as zidovudine (AZT). The treatment representing this invention is based upon cell differentiating agents, termed antineoplastons.
The present inventor postulates that the human body possesses a biochemical defense system consisting of anti-neoplastons, which are small and medium size peptides and amino acid derivatives (Burzynski, Internat. J. Exp. Clin. Chemother., 2:63 (1989)). The basis of defense in this system is reprogramming of the cells which contain the wrong program for development. Such theory has been tested in the treatment of cancer by inducing normal differentiation in cancer cells (Burzynski, U.S. Pat. Nos. 4,470,970, 4,558,057 and 4,559,325).
Antineoplaston A10 was the first active ingredient isolated and synthetically produced (Burzynski et al., Proc. 13 Internat. Cong. Chemother., Vienna, Austria, 17:P.S.12.4.11-4). Antineoplaston A10, which chemically is 3-phenylacetylamino-2,6-piperidinedione, undergoes enzymatic hydrolysis in human intestine to form phenylacetylglutamine and phenylacetylisoglutamine in the ratio of 4:1. Pharmaceutical formulations of the two digestion products of Antineoplaston A10 was named Antineoplaston A10 injections (Burzynski, Internat. JournaI Exp. Clin. Chemother., 2:63 (1989). See also U.S. Pat. Nos. 4,470,970, 4,558,057 and 4,559,325). Acid hydrolysis of Antineoplaston A10 initially produces phenylacetylglutamine and phenylacetylisoglutamine. When hydrolysis is carried further, the products of reaction include phenylacetic acid, glutamic acid and ammonia. The sodium salt of phenylacetylglutamine was named Antineoplaston AS2-5 and the mixture of the sodium salts of phenylacetylglutamine and phenylacetic acid in the ratio of 1:4 was named Antineoplaston AS2-1 (Burzynski, Internat. Journal Exp. Clin. Chemother., 2:63 (1989)).